Federal health officials have announced a Class I recall involving certain Boston Scientific implantable defibrillators, following dozens of reports involving problems where electrodes fractured and failed to provide electrical shock treatments, which may have resulted in more than two dozen serious injuries and one death.
The U.S. Food and Drug Administration (FDA) announced the Boston Scientific defibrillator recall on February 10, warning that the electrodes for the implantable life-saving devices have the potential to fracture at a specific point which could cause operation failure.
The recall affects the EMBLEM S-ICD Subcutaneous Electrode Model 3501, which is part of Boston Scientific S-ICD System implantable cardioverter defibrillators. The devices are implanted under a patient’s skin in the upper chest area to provide electrical shock therapy to stop dangerous heart rhythms or cardiac arrest.
Boston Scientific and the FDA are aware of at least 27 complaints regarding the implanted device fracturing, resulting in at least 26 serious injuries and one reported death.
Officials warn that in the event of the device fracturing, it could become unable to deliver therapy to slow very fast heartbeats from cardiac arrest, or could require the need for additional surgery to replace failed devices.
Boston Scientific issued an Important Medical Device Advisory letter on December 2, 2020, instructing healthcare professionals to promptly identify patients with the impacted devices implanted to notify them of the issue and evaluate the risks of using affected devices compared to replacing them.
The manufacturer also recommended healthcare professionals modify their patient monitoring schedules by using the LATITUDE remote monitoring system to detect any alerts and to perform a system follow-up every three months. Patients with suspected device fractures should undergo chest radiography of the entire electrode length to confirm.
While the manufacturer recommends replacing any electrode that is shown to have signs of a break with high impedance alert, routine replacement of an electrode without fracture evidence is not recommended.
However, patients with a history of life-threatening ventricular arrhythmias, who are unable to reliably follow up every three months, or those who are unable to hear beeping tones from the LATITUDE monitoring system should evaluate the risks they could face due to an electrode fracture, the manufacturer warned.
The devices were manufactured by Boston Scientific of Marlborough, Massachusetts. They were distributed from June 2017 to present. The manufacturer indicates approximately 19,919 units are impacted by the recall.
The FDA has classified the recall as a Class I recall, indicating it is the most serious of its kind, and there is a reasonable probability that the use of the product will cause serious adverse health consequences or death.
Customers or healthcare professionals with additional questions are being encouraged to contact Boston Scientific Technical Services at (800)-CARDIAC (227-3422) or by email at firstname.lastname@example.org.